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510(k) K990406

KINGLI ACUPUNCTURE NEEDLE by United Pacific Co., Ltd. — Product Code MQX

K990406 is an FDA 510(k) premarket notification submitted by United Pacific Co., Ltd. for the device "KINGLI ACUPUNCTURE NEEDLE". The FDA issued a decision of Substantially Equivalent on April 16, 1999. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580. United Pacific Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1999
Date Received
February 9, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Acupuncture, Single Use
Device Class
Class II
Regulation Number
880.5580
Review Panel
HO
Submission Type

Other clearances by United Pacific Co., Ltd.

  • K003010 — SPIRIT ACUPUNCTURE NEEDLE (October 19, 2000)
  • K001718 — MILLENNIA ACUPUNCTURE NEEDLE (June 21, 2000)
  • K993123 — QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A (December 17, 1999)
  • K991503 — SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36 (July 28, 1999)

Other clearances for product code MQX

  • K162566 — AIK Sterile Acupuncture Needles for Single Use (May 11, 2017)
  • K142760 — Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles (August 25, 2015)
  • K150903 — EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, (July 15, 2015)
  • K142920 — KM Needles (Acupuncture Needle) (June 10, 2015)
  • K141473 — SMC ACUPUNCTURE NEEDLE (August 1, 2014)
  • K132896 — CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, (December 2, 2013)
  • K111392 — WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) (November 4, 2011)
  • K103061 — BIOMATE STERILE ACUPUNCTURE NEEDLE (June 20, 2011)
  • K092240 — ACUPUNCTURE NEEDLES (April 21, 2010)
  • K090199 — JIAJIAN ACUPUNCTURE NEEDLE (August 11, 2009)

FDA data resources